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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ROZANOLIXIZUMAB-NOLI: 349 Adverse Event Reports & Safety Profile

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349
Total FAERS Reports
4 (1.1%)
Deaths Reported
84
Hospitalizations
349
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761286 ·

First Report: 20230101 · Latest Report: 20250805

What Are the Most Common ROZANOLIXIZUMAB-NOLI Side Effects?

#1 Most Reported
Myasthenia gravis
57 reports (16.3%)
#2 Most Reported
Drug ineffective
51 reports (14.6%)
#3 Most Reported
Headache
48 reports (13.8%)

All ROZANOLIXIZUMAB-NOLI Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myasthenia gravis 57 16.3% 0 28
Drug ineffective 51 14.6% 0 11
Headache 48 13.8% 0 11
Nausea 29 8.3% 1 9
Diarrhoea 27 7.7% 1 9
Fatigue 27 7.7% 0 6
Dyspnoea 19 5.4% 1 10
Hospitalisation 19 5.4% 1 19
Vomiting 17 4.9% 1 7
Therapy interrupted 15 4.3% 0 5
Asthenia 14 4.0% 0 8
Off label use 14 4.0% 0 5
Product dose omission issue 13 3.7% 0 7
Pyrexia 13 3.7% 0 5
Dizziness 12 3.4% 0 5
Rash 12 3.4% 0 1
Dysphagia 11 3.2% 0 6
Myasthenia gravis crisis 11 3.2% 0 5
Malaise 10 2.9% 1 4
Weight increased 10 2.9% 0 1

Who Reports ROZANOLIXIZUMAB-NOLI Side Effects? Age & Gender Data

Gender: 63.3% female, 36.7% male. Average age: 55.1 years. Most reports from: US. View detailed demographics →

Is ROZANOLIXIZUMAB-NOLI Getting Safer? Reports by Year

YearReportsDeathsHosp.
2023 24 0 5
2024 110 1 34
2025 56 3 20

View full timeline →

What Is ROZANOLIXIZUMAB-NOLI Used For?

IndicationReports
Myasthenia gravis 233
Product used for unknown indication 103

ROZANOLIXIZUMAB-NOLI vs Alternatives: Which Is Safer?

ROZANOLIXIZUMAB-NOLI vs RUBIDIUM RB-82 ROZANOLIXIZUMAB-NOLI vs RUCAPARIB ROZANOLIXIZUMAB-NOLI vs RUCAPARIB CAMSYLATE ROZANOLIXIZUMAB-NOLI vs RUFINAMIDE ROZANOLIXIZUMAB-NOLI vs RUPATADINE ROZANOLIXIZUMAB-NOLI vs RUXOLITINIB ROZANOLIXIZUMAB-NOLI vs SABRIL ROZANOLIXIZUMAB-NOLI vs SACCHAROMYCES CEREVISIAE ROZANOLIXIZUMAB-NOLI vs SACITUZUMAB GOVITECAN ROZANOLIXIZUMAB-NOLI vs SACITUZUMAB GOVITECAN-HZIY

Official FDA Label for ROZANOLIXIZUMAB-NOLI

Official prescribing information from the FDA-approved drug label.